NCT06962098

Brief Summary

This study is a multicenter, double-blinded, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and efficacy of Isuzinaxib compared with placebo in subjects with DKD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for phase_2

Timeline
26mo left

Started May 2025

Typical duration for phase_2

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
May 2025Jun 2028

First Submitted

Initial submission to the registry

April 16, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

May 26, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

April 16, 2025

Last Update Submit

July 14, 2025

Conditions

Diabetic Kidney Disease (DKD)

Keywords

IsuzinaxibAPX-115NOXDiabetic NephropathyDNDiabetic Kidney DiseaseDKD

Outcome Measures

Primary Outcomes (1)

  • Efficacy endpoint: Urine Albumin-Creatinine Ratio

    Change in Urine Albumin-Creatinine Ratio from baseline through Week 24 in the Isuzinaxib treatment groups versus the placebo group

    Over 24 Weeks

Secondary Outcomes (6)

  • Efficacy endpoint: eGFR

    Over 24 Weeks

  • Efficacy endpoint: Urine Albumin-Creatinine Ratio

    Over 20 Weeks

  • Efficacy endpoint: Urine Albumin-Creatinine Ratio decrease

    Over 24 Weeks

  • Efficacy endpoint: Incidence of Composite Renal Outcome

    Over 24 Weeks

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Over 24 Weeks

  • +1 more secondary outcomes

Other Outcomes (2)

  • Plasma Biomarkers

    Over 24 Weeks

  • Urinary Biomarkers

    Over 24 Weeks

Study Arms (3)

Isuzinaxib 400 mg

ACTIVE COMPARATOR

Subject will receive the 400 mg of Isuzinaxib.

Drug: Isuzinaxib

Isuzinaxib 200 mg

ACTIVE COMPARATOR

Subject will receive the 200 mg of Isuzinaxib.

Drug: Isuzinaxib

Placebo

PLACEBO COMPARATOR

Subject will receive the Placebo.

Drug: Placebo

Interventions

IsuzinaxibDRUG

Oral dosing regimen once daily

Also known as: APX-115
Isuzinaxib 200 mgIsuzinaxib 400 mg
PlaceboDRUG

Oral dosing regimen once daily

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male/female subject aged ≥19 years inclusive at the time of informed consent.
  • Clinical diagnosis of type 2 diabetes and DKD.
  • kg/m² \< body mass index \< 35 kg/m².
  • Stable UACR values prior to screening visit.
  • UACR between 200 and 3000 mg/g.
  • Hemoglobin A1c ≤10% at Screening Visit.
  • Subject who has been taking unchanged dosage of angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) medication.
  • Subject who has been on stable anti-hyperglycemic prior to screening.
  • Females of childbearing potential/sexually active males with a partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control.
  • Willing to be under dietary management for diabetes.
  • Willing to comply with all study procedures and availability for the duration of the study.
  • Capable of understanding the content of and able voluntarily to provide a signed and dated written informed consent form (ICF) prior to any study procedures.

You may not qualify if:

  • History of type 1 diabetes mellitus or gestational diabetes.
  • Subject's renal impairment and/or albuminuria is considered to be of origin other than DKD.
  • History of renal transplant and/or plan to undergo a renal transplant during the study.
  • History of acute kidney injury or renal dialysis.
  • Subject with uncontrolled blood pressure.
  • Subject taking immunosuppressant.
  • Subject with known or suspected hypersensitivity to any components of the APX-115 formulation.
  • Clinically significant abnormal laboratory findings at screening.
  • History of drug or alcohol abuse within 1 year prior to screening.
  • History of any cardiovascular event or cardiovascular procedure planned during the clinical study.
  • Current or history of New York Heart Association class III or IV heart failure.
  • Clinically significant electrocardiogram (ECG) abnormalities.
  • Known significant liver disease.
  • Subject with active urinary tract infection or has not fully recovered before randomization.
  • History of malignancy within 5 years prior to screening.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Korea University Ansan Hospital

Ansan-si, South Korea

RECRUITING

Inje university Busan Paik Hospital

Busan, South Korea

NOT YET RECRUITING

Pusan National University Hospital

Busan, South Korea

RECRUITING

SoonChunHyang University Hospital Cheonan

Cheonan, South Korea

RECRUITING

Keimyung University Daegu Dongsan Hospital

Daegu, South Korea

RECRUITING

Inje university Ilsan Paik Hospital

Goyang-si, South Korea

RECRUITING

Hanyang University Guri Hospital

Guri-si, South Korea

RECRUITING

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, South Korea

RECRUITING

The Catholic University of Korea Incheon St. Mary's Hospital

Incheon, South Korea

RECRUITING

Jeonbuk National University Hospital

Jeonju, South Korea

NOT YET RECRUITING

CHA Bundang Medical Center

Seongnam-si, South Korea

RECRUITING

Boramae Medical Center

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Kyung Hee University Hospital at Gangdon

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

The Catholic University of Korea Seoul ST.MARY'S Hospital

Seoul, South Korea

RECRUITING

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, South Korea

NOT YET RECRUITING

Pusan National University Yangsan Hospital

Yangsan, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

isuzinaxib

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Central Study Contacts

Sung Jun Lim

CONTACT

+82-31-365-3693cd@aptabio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2025

First Posted

May 8, 2025

Study Start

May 26, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

July 18, 2025

Record last verified: 2025-07

Locations

KR(20)